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NCT01496014 · ClinicalTrials.gov registry record
Assessment of Severe Extremity Wound Bioburden at the Time of Definitive Wound Closure or Coverage
A clinical trial of Open Fracture, sponsored by Major Extremity Trauma Research Consortium.
- Completed
- Registry status
- 600
- Enrollment target
- 20
- Study locations
NCT01496014: Completed study of Open Fracture, sponsored by Major Extremity Trauma Research Consortium.
NCT01496014 is a study of Open Fracture that has completed, run by Major Extremity Trauma Research Consortium. The registered enrollment target is 600 participants. The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01496014, a study of Open Fracture, has completed, sponsored by Major Extremity Trauma Research Consortium.
- COMPLETED
- Registry status
- 600 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to characterize the bacteria in the wound "bioburden" at the time of definitive wound coverage/closure of severe tibia fractures in both the military and civilian populations.
Primary Outcome
The presence of a deep surgical site infection will be defined by the criteria of the Centers for Disease Control. Deep SSI occurs within 30 days after the operation if no implant is left in place, or within one year if implant is in place and the infection appears to be related to the operation.
Conditions Studied
Study Locations (20)
Maryland
- University of Maryland, R Adams Cowley Shock Trauma Center - Baltimore
- Walter Reed Military Medical Center - Bethesda
- Walter Reed National Military Medical Center - Bethesda
California
- Naval Medical Center San Diego - San Diego
- UCSF Medical Center - San Francisco
Florida
- University of Miami Ryder Trauma Center - Miami
- Florida Orthopaedic Institute - Tampa
Minnesota
- Hennepin County Medical Center / Minneapolis - Minneapolis
- Regions Hospital - Saint Paul
Missouri
- Barnes Jewish Hospital - St Louis
- St. Louis Medical Center - St Louis
Colorado
- Denver Health and Hospital Authority - Denver
Georgia
- Emory University Dept of Orthopaedics - Atlanta
Indiana
- OrthoIndy at St Vincent - Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 600 participants |
| Start Date | 2011-09 |
| Est. Completion | 2022-06-30 |
What the finished NCT01496014 record still lists
NCT01496014 is an observational study that tracks outcomes without assigning an intervention. The registered 600 participants enrollment target is mid-sized for trials with a published cap.
The record links to 1 condition, with Open Fracture appearing as the primary indexed condition, and to 0 interventions.
NCT01496014 names 20 study sites across 14 states, led by Maryland, California, Florida.
Frequently Asked Questions
What is clinical trial NCT01496014 about?
NCT01496014 is a clinical study titled "Assessment of Severe Extremity Wound Bioburden at the Time of Definitive Wound Closure or Coverage". The purpose of this study is to characterize the bacteria in the wound "bioburden" at the time of definitive wound coverage/closure of severe tibia fractures in both the military and civilian populations.
What is the current status of trial NCT01496014?
This trial is currently completed. The enrollment target is 600 participants. The study started on 2011-09. Estimated completion is 2022-06-30.
What conditions does trial NCT01496014 study?
This clinical trial studies the following conditions: Open Fracture.
Who is sponsoring clinical trial NCT01496014?
This trial is sponsored by Major Extremity Trauma Research Consortium, which has 30 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01496014 being conducted?
This trial has 20 study locations across California, Colorado, Florida, Georgia, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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